CompletedNot Applicable

AttraX® Putty vs. Autograft in XLIF®

Brazil45 participantsStarted 2014-12

Plain-language summary

The objective of this study is to evaluate the clinical success of AttraX Putty as a bone graft substitute for autograft in XLIF procedures.

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Persistent back and/or leg pain unresponsive to conservative treatment for at least 6 months, unless surgical treatment is clinically indicated sooner
✓. Indicated for a single-level XLIF between L1 and L5 with bilateral percutaneous pedicle screws
✓. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
✓. 18-80 years of age at the date of written informed consent
✓. Able to undergo surgery based on physical exam, medical history, and surgeon judgment
✓. Expected to survive at least 2 years beyond surgery
✓. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
✓. Signed and dated informed consent form

✕. Mental or physical condition that would limit the ability to comply with study requirements
✕. Spine abnormality requiring treatment at more than one level
✕. Previous failed fusion at any spinal level
✕. Prior fusion procedure at operative level (i.e., no revision of operative level)
✕. Prior adjacent level fusion (note: prior decompression is not an exclusion)
✕. Systemic or local infection; active or latent
✕. Diseases that significantly inhibit bone healing (e.g., prior diagnosis of osteoporosis, metabolic bone disease)
✕. Treatment with pharmaceuticals interfering with calcium metabolism

The number and percentage of subjects with radiographically apparent fusion 24 months.

Timeframe: 24-months

NCT IDNCT02250248

SponsorNuVasive

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05-21

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Persistent back and/or leg pain unresponsive to conservative treatment for at least 6 months, unless surgical treatment is clinically indicated sooner
✓. Indicated for a single-level XLIF between L1 and L5 with bilateral percutaneous pedicle screws
✓. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
✓. 18-80 years of age at the date of written informed consent
✓. Able to undergo surgery based on physical exam, medical history, and surgeon judgment
✓. Expected to survive at least 2 years beyond surgery
✓. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
✓. Signed and dated informed consent form

✕. Mental or physical condition that would limit the ability to comply with study requirements
✕. Spine abnormality requiring treatment at more than one level
✕. Previous failed fusion at any spinal level
✕. Prior fusion procedure at operative level (i.e., no revision of operative level)
✕. Prior adjacent level fusion (note: prior decompression is not an exclusion)
✕. Systemic or local infection; active or latent
✕. Diseases that significantly inhibit bone healing (e.g., prior diagnosis of osteoporosis, metabolic bone disease)
✕. Treatment with pharmaceuticals interfering with calcium metabolism